UK Aligns with the EU on Formaldehyde Releasers in Cosmetics
- Daniel Jiménez
- 11 hours ago
- 5 min read
The United Kingdom has introduced stricter labelling requirements for cosmetic products containing formaldehyde-releasing preservatives, reducing the threshold that triggers the mandatory warning “releases formaldehyde”.
This update brings the UK approach closer to the EU framework and is particularly relevant for brands selling cosmetic products in both the European Union and Great Britain.
Table of contents
What are formaldehyde releasers?
Formaldehyde itself is prohibited as an intentional cosmetic ingredient. However, certain preservatives permitted in cosmetics may release small amounts of formaldehyde over time or during product use.
These substances are commonly known as formaldehyde releasers or formaldehyde donors. They may be used for preservation purposes, particularly in products where microbiological stability is a key concern.
Examples of ingredients that may be associated with formaldehyde release include:
DMDM Hydantoin
Diazolidinyl Urea
Imidazolidinyl Urea
Sodium Hydroxymethylglycinate
Bronopol
The presence of one of these ingredients does not automatically mean that a product is non-compliant. However, it does mean that the amount of formaldehyde released in the finished product must be properly assessed.
What has changed?
The key change is the reduction of the labelling threshold for formaldehyde released in the finished cosmetic product.
Previously, the warning was triggered at: 0.05% free formaldehyde, equivalent to 500 ppm
The new threshold is: 0.001% free formaldehyde, equivalent to 10 ppm
This is a significant reduction. It means that products which previously did not require a formaldehyde-related warning may now fall within the scope of the labelling requirement.
Where the total concentration of formaldehyde released in the finished product exceeds 0.001%, the product label must include the warning: “releases formaldehyde”
Why is this important?
The change is intended to improve consumer protection, particularly for individuals already sensitised to formaldehyde.
From a regulatory perspective, this is not only a labelling update. It also affects the way brands, manufacturers, safety assessors and Responsible Persons should approach product compliance.
A simple INCI review may no longer be sufficient. Companies may need to verify the actual level of formaldehyde released in the finished product, especially where formaldehyde-releasing preservatives are used.
EU and UK timelines
For companies placing products on the market in both jurisdictions, this alignment may reduce regulatory divergence, but it also requires a careful review of formulations, supplier documentation, safety assessments and product labels.
European Union
The EU introduced the lower threshold through Commission Regulation (EU) 2022/1181.
For the EU market:
Products placed on the market from 31 July 2024 must comply with the new labelling threshold.
Products already placed on the market before 31 July 2024 may continue to be made available until 31 July 2026, where applicable under the transitional provisions.
Great Britain
The UK has now introduced a similar approach under its retained cosmetics framework.
For Great Britain:
Products placed on the market from 15 August 2026 must comply with the updated formaldehyde labelling threshold.
Products already placed on the market before that date may continue to be made available until 14 February 2027, where applicable under the transitional provisions.
This means that brands selling in both the EU and UK should not assume that an old label remains acceptable. The compliance status must be assessed separately for each market and according to the relevant deadline.
What does this mean for cosmetic brands?
1. Formulation review
Brands should identify all products containing formaldehyde-releasing preservatives and determine whether they may release formaldehyde above the new 0.001% threshold.
This is especially important for leave-on products, products intended for sensitive skin, baby products, intimate care products, and products marketed with mildness or skin tolerance claims.
2. Supplier documentation
Raw material suppliers should be asked to provide updated information on formaldehyde release, including technical data, specifications, impurity information and any available analytical results.
Where supplier information is insufficient, additional assessment or finished product testing may be necessary.
3. Finished product testing
At such a low threshold, assumptions based only on the ingredient list may not be enough. Analytical testing of the finished product may be needed to confirm whether the warning is required.
This is particularly relevant where more than one formaldehyde-releasing preservative is used, or where the formulation conditions may influence formaldehyde release.
4. Safety assessment and PIF update
The Product Information File should reflect the updated assessment. This may include:
review of the preservative system;
evaluation of formaldehyde release;
supplier documentation;
analytical data, where available;
safety assessor justification;
updated label review.
For products sold in both the EU and UK, the PIF or UK PIF should demonstrate that the product has been reviewed against the applicable market requirements.
5. Label and claims review
If the product exceeds the new threshold, the label must include the warning “releases formaldehyde”.
Brands should also consider whether certain claims remain appropriate. For example, products positioned as “gentle”, “for sensitive skin”, “clean”, “free from controversial preservatives” or similar may require a more careful regulatory and marketing review.
Even where the ingredient remains legally permitted, the presence of a formaldehyde-related warning may affect consumer perception and retailer acceptance.
Practical impact for companies selling in both the EU and UK
This update is important because it reduces one area of post-Brexit divergence. Brands may be able to work towards a more harmonised EU/UK compliance strategy for products containing formaldehyde releasers.
However, the deadlines are not identical. A product may already require action in the EU while still benefiting from a UK transition period, depending on when it was placed on each market.
For this reason, companies should avoid treating EU and UK compliance as automatically interchangeable. Each product should be reviewed against the correct market, date and label version.
Recommended next steps
Cosmetic brands should:
identify products containing formaldehyde-releasing preservatives;
request updated documentation from raw material suppliers;
assess the level of formaldehyde released in the finished product;
determine whether analytical testing is necessary;
update the safety assessment and Product Information File;
review labels and claims;
prepare transition plans for stock already placed on the market;
Ensure EU and UEK requirements are assessed separately.
How BELAB Services can help
Belab Services supports cosmetic brands with EU and UK regulatory compliance, including formulation review, ingredient assessment, label compliance, Product Information File updates and Responsible Person services.
If your products contain formaldehyde-releasing preservatives, or if you are unsure whether the new warning applies, we can help you assess the regulatory impact and define the next steps before the applicable deadlines.
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